Health System Bears Cost of Implants With No Warranties

In January, William R. Morris’s artificial hip, just three years old, was failing so badly that it had to be replaced during an extensive procedure that cost about $50,000.

The maker of the failed hip has since sent letters to Mr. Morris’s doctor, but none offering to cover replacement expenses for the device, which typically is expected to last 15 years.

“They keep asking for the joint so they can look at it,” said Mr. Morris, a 52-year-old oil industry geologist who lives in Anchorage.

When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers.

The million or so artificial hips and knees implanted each year in the United States, they say, are normally not guaranteed. Instead, the costs of replacing implants that fail early because of design or mechanical problems — devices that sell for as much as $15,000 each — are largely paid by Medicare, insurance companies and patients.

Implants can fail for many reasons, but if only a small percentage of them fail prematurely because they are substandard, the costs to taxpayers, policyholders and patients can run into the tens of millions of dollars each year, health care experts estimate.

Orthopedic producers may sometimes even profit from the failures because they sell the replacements at full price.

“Companies have dumped these costs into the health care system,” said Dr. Lawrence D. Dorr, an orthopedic surgeon in Los Angeles who two years ago took the unusual step of drawing attention to one problematic hip device. “They don’t have any skin in the game.”

The costs imposed by poorly performing medical devices were not dealt with in the landmark health care legislation that Congress passed last month. To pay for part of the overhaul, lawmakers mandated an excise tax on implant sales that is intended to bring in $20 billion over the next decade.

Patient advocates say an important opportunity was lost. Arthur Levin, the executive director of the Center for Medical Consumers, an advocacy group in New York, said it was appalling that the manufacturers did not provide warranties, given how critical such implants are for patients. By contrast, makers of another widely used and costly category of implants, heart devices like defibrillators, have issued warranties for more than 30 years and have provided free or discounted replacements when devices fail prematurely.

“Either they do not have faith in their products, or they are just saying tough luck to patients,” Mr. Levin said, referring to the makers of orthopedic implants. “It borders on unethical business behavior.”

Those manufacturers may cover the cost of replacement surgeries in some circumstances, as when they face lawsuits. Generally, however, patients are unaware of the industry’s no-warranty policy. Three of the six major orthopedic implant manufacturers in the United States did not respond to inquiries about whether they offered warranties.

Another manufacturer, Zimmer Holdings of Warsaw, Ind., said the longevity of a hip implant depended on many factors beyond the company’s control, including a surgeon’s skill, a patient’s weight and a patient’s adherence to postoperative restrictions on activity.

“Because of the multifactorial nature of the survival of an implant in a particular patient, revision surgeries are to be expected,” said Zimmer, using the medical term for a replacement operation. “Therefore, we do not provide free or discounted replacement revision products when one of Zimmer’s implants needs to be revised.”

Photo

William R. Morris had his three-year-old artificial hip replaced in January because it was failing. It was his third hip replacement since 2006.Credit
Joshua Borough for The New York Times

The producer the implant removed from Mr. Morris this year, the DePuy Orthopaedics division of Johnson & Johnson, also said it did not guarantee its devices. “While we don’t have product warranties, we evaluate and address all complaints and issues on a case-by-case basis and take actions based on the specific circumstances,” the company said in a statement.

Stan Mendenhall, the editor of Orthopedic Network News, an industry publication, said he was unaware of any major producer of hips and knees that offered a warranty in this country.

As the population ages, the use of artificial hips and knees is growing fast, providing a lucrative market for device manufacturers. Sales of artificial hips and knees in this country reached an estimated $6.7 billion last year, and the devices have one of the highest profit margins of any medical product. An artificial joint can cost $3,000 to $15,000.

Many implants work well, lasting 15 years or more before they wear out and need replacing. It is impossible to know how many artificial hips and knees fail early because of design or manufacturing problems, because the United States, unlike some other countries, has no database to track such procedures. Also, implant companies and doctors say that such devices primarily fail because of issues unrelated to the product.

The makers sell implants to hospitals, rather than to patients directly. The costs are passed along to taxpayers and policyholders when hospitals recover such expenses from Medicare or private insurers. Patients with private insurance also bear a portion of the costs though co-payments.

For Mr. Morris, the procedure he underwent in January was his third hip replacement since 2006. The first one failed that same year. In mid-2006, he received another replacement. For about a year, he felt good, but then his joints became so painful and inflamed that he thought he might be dying.

His employer’s insurance covered most of his costs, but Mr. Morris estimates that his co-payments and other out-of-pocket costs were well over $10,000 for the initial replacement and the two additional surgeries.

Orthopedic specialists say that subsequent replacement procedures are typically more complex than the initial operations, and patients undergoing them face a significantly higher risk of lasting complications like nerve damage.

The type of artificial hip that Mr. Morris had taken out in January, called an ASR and made by DePuy Orthopaedics, has been particularly problematic. In early March, the company issued an alert that new data suggested the device was failing in some patients within a few years of implant.

Medical reports since 2008 have indicated that the hip might be flawed and capable of generating high levels of metallic debris, and a top DePuy consultant has said that he and company officials realized two years ago that it was particularly difficult for surgeons to implant properly; DePuy maintains that the device is safe.

The Food and Drug Administration has received about 300 reports of early replacement operations involving ASR patients since 2008. Safety experts say that the actual number of such procedures is most likely far higher, because many implant failures are not reported to the agency.

For his part, Mr. Levin, the patient advocate, says he is disturbed that orthopedic surgeons have not done more to force greater accountability on the part of manufacturers, particularly since as a profession the surgeons accept tens of millions of dollars annually in consulting fees from implant makers.

As it turns out, one manufacturer, Biomet, does offer warranties, though it may not do so in this country.

According to the Web site of its subsidiary in Britain, the company offers a 10-year warranty on some products, including certain knee, hip and shoulder implants, and provides a “free of charge replacement” if one fails. The Biomet Web site in the United States makes no mention of warranties. Company officials declined to be interviewed and did not respond to written questions.

In a marketing brochure on the British site, the Biomet unit claims that the warranted devices are so durable that it has had just over a dozen claims since 1997, when the program began.

“We believe that all customer requirements should be met,” the brochure states. It adds: “More than orthopaedic solutions, we deliver a true first-class service.”

A version of this news analysis appears in print on April 3, 2010, on page A1 of the New York edition with the headline: Implant at Own Risk. Order Reprints|Today's Paper|Subscribe